Skip to Content

LORAZEPAM 1MG/ML ORAL SOLUTION

Active substance(s): LORAZEPAM / LORAZEPAM / LORAZEPAM

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the user

Lorazepam 1mg/ml Oral Solution

Read all of this leaflet
carefully before you start
taking this medicine
because it contains important
information for you.






Keep this leaflet. You may need to
read it again.
If you have any further questions,
ask your doctor or pharmacist.
This medicine has been prescribed
for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as
yours.
If you get any side effects, talk to
your doctor or pharmacist. This
includes any possible side effects not
listed in this your leaflet. See section 4.

The name of your medicine is Lorazepam
1mg/ml Oral Solution but it will be referred
to as 'Lorazepam' throughout this leaflet.
What is in this leaflet
1. What Lorazepam is and what it
is used for
2. What you need to know before
you take Lorazepam
3. How to take Lorazepam
4. Possible side effects
5. How to store Lorazepam
1mg/ml Oral Solution
6. Contents of the pack and other
information
1.

What Lorazepam is and what
it is used for

Lorazepam is a member of a group of
medicines called benzodiazepines. It can
help to relieve anxiety. Lorazepam is
prescribed as short-term therapy for
anxiety (2-4 weeks), or sleeping
difficulties due to anxiety that significantly
affects normal daily life. It may also be
used as a sedative before surgery or
operative dental treatment.
Lorazepam is not to be used for longer
than 4 weeks or to treat mild or
moderate anxiety in adults.

Other medicines and
Lorazepam
Tell your doctor or pharmacist that you
are taking lorazepam before taking any
other medicine or if you enter hospital
for treatment, or if you are taking any
other medicines, including those which
have not been prescribed by a doctor,
since they may affect the way
Lorazepam works.
Lorazepam may also affect the way
other drugs work. In particular, you
should tell your doctor if you are taking
any other sedative (e.g. barbiturates or
antihistamines), anti-anxiety drugs,
anti-depressants, strong pain killers
(e.g. methadone), drugs for epilepsy
(e.g. phenobarbital or valproate),
antihistamines, or drugs for mood or
mental disorders (e.g. chlorpromazine,
loxapine or clozapine), drugs for
cataplexy; treating HIV; to treat
delusions or hallucinations; to help with
indigestion (e.g. cisapride or
omeprazole); muscle relaxants (e.g.
baclofen and tizanidine); drugs for
addiction treatment (e.g. lofexidine and
disulfiram); TB drugs such as isoniazid;
antibiotics such as erythromycin; drugs
to treat high blood pressure; Parkinson's
disease drugs e.g. levodopa; oestrogencontaining contraceptives and drugs for
asthma (theophylline). The dose of
these drugs may need to be reduced
before you can take lorazepam.
Lorazepam with food, drink and
alcohol.
Grapefruit juice and drinks containing
caffeine should be avoided as they can
affect the way that Lorazepam works.
Do not drink alcohol while you are taking
Lorazepam.
Pregnancy and
breast-feeding


2. What you need to know

before you take Lorazepam


Do not take Lorazepam:










if you have severe breathing or
chest problems
if you are allergic to
benzodiazepines or any of the other
ingredients in Lorazepam (see list
under ‘What Lorazepam contains’)
if you have myasthenia gravis (very
weak or tired muscles)
if you have serious liver problems
if you suffer from sleep apnoea
(breathing problems when you are
asleep)
if you are breast-feeding, since the
drug may pass into breast milk.
if you are planning a pregnancy or
are pregnant.

If you have been only prescribed
Lorazepam for anxiety and no other
medications, please consult with your
doctor whether other medications should
also be prescribed.
When special care is required with
Lorazepam
Please consult your doctor if any of the
following apply:

if you abuse or have in the past
abused drugs or alcohol

if you have a personality disorder. If
so, you have a greater chance of
becoming dependent on lorazepam

if you have any kidney or liver
problems

if you are suffering from depression,
since lorazepam may increase any
suicidal feelings which you may
have

if you have suffered from
depression before, since it could reoccur during treatment with
lorazepam

if you suffer from breathing
problems

if you are suffering from an eye
problem called glaucoma e.g. high
pressure within the eye

PIL/UK/MFG024/05/v6



Do not take this medicine if you are
pregnant, or might become
pregnant, without consulting your
doctor. Benzodiazepines, including
lorazepam, may cause damage to
the foetus if taken during early
pregnancy.
If you take this medicine during late
pregnancy or during labour, your
baby, when born, may be less
active than other babies, have a low
body temperature, be floppy, or
have breathing or feeding
difficulties for a while. Your baby’s
response to the cold might be
temporarily impaired. If this
medicine is taken regularly in late
pregnancy, your baby may develop
withdrawal symptoms after birth.
Do not take this medicine if you are
breast-feeding, since the drug may
pass into breast milk, and cause the
baby to be less active and unable to
suckle.

Driving and using machines
Lorazepam may make you feel dizzy,
sleepy or forgetful during the day, or
may affect your concentration. This may
affect your performance at skilled tasks
such as driving machinery or operating
machinery by affecting your vision or
muscle function. You should not take
part in any other activities where this
could put yourself or others at risk.
You should avoid alcohol while you are
taking lorazepam, since this may make
you very drowsy and seriously affect
your ability to drive or use machines.
The medicine can affect your ability to
drive as it may make you feel sleepy or
dizzy.

Do not drive while taking this
medicine until you know how it
affects you.

It is an offence to drive if this
medicine affects your ability to
drive.

However, you would not be
committing an offence if:
• The medicine has been
prescribed to treat a medical or
dental problem and




You have taken it according to
the instructions given by the
prescriber or in the information
provided with the medicine and
It was not affecting your ability
to drive safely.

Talk to your doctor or pharmacist if you
are not sure whether it is safe for you to
drive while taking this medicine.
Lorazepam 1mg/ml Oral Solution
contains:
This medicinal product contains
small amount of ethanol (alcohol),
less than 100mg per ml. The amount of
ethanol 96% in each ml is 20.21mg.

3. How to take Lorazepam
Always take Lorazepam 1mg/ml Oral
Solution exactly as your doctor has told you.
The label on your medicine should also tell
you. You should check with your doctor or
pharmacist if you are not sure.
Adults

Anxiety: 1 - 4 ml (1 - 4mg) daily in
divided doses. Your doctor will tell
you how often to take the medicine.

Sleeping Problems: 1 - 2ml (1 2mg) before going to sleep. You
should make sure that you will be
able to sleep for 7 to 8 hours before
taking the medicine.

Before Surgery: 2 - 3ml (2 - 3mg)
the night before your operation and
2 - 4ml (2 - 4mg) 1 or 2 hours
before your operation.
Elderly or patients with liver or
kidney problems
Lower doses may be sufficient in these
patients. They may respond to half the
usual adult dose or less.
Lorazepam is not recommended for
use in children.
Lorazepam is usually prescribed for
short courses of treatment, lasting from
a few days to 4 weeks including a dose
reduction at the end. This reduces the
risk of becoming dependent on
Lorazepam, or suffering unpleasant
effects when you stop taking the
medicine (See 'If you stop taking
Lorazepam' section).
The beneficial effect of Lorazepam may
be less apparent after several weeks of
use. If you are given lorazepam for
more than 4 weeks, your doctor might
want to take blood samples occasionally
to check your blood and liver, since
drugs like lorazepam have occasionally
affected blood and liver function.
Method of administration:
This medicinal product contains medium chain
triglycerides which reacts with polystyrene
materials and makes it brittle upon contact.
Do not use polystyrene dosing devices for
measuring the dose.
Use the measuring syringe provided in
the pack to deliver the required dose orally.
The required dose should be drawn from the
container into the graduated syringe
provided using the syringe adaptor (see
detailed instructions below). The syringe
should be held in the mouth of the patient,
and the contents of the syringe should then
be ejected into the mouth and swallowed.
Instructions for the use of syringe:
a) Open the bottle: press the cap and
turn it anticlockwise (figure 1).
b) Separate the adaptor from the
syringe (figure 2). Insert the adaptor
into the bottle neck (figure 3). Ensure it
is properly fixed. Take the syringe and
put it in the adaptor opening (figure 4).

TURN OVER

c) Turn the bottle upside down. Fill the
syringe with a small amount of solution
by pulling the piston down (figure 5A),
then push the piston upwards in order to
remove any possible bubble (figure 5B).
Pull the piston down to the graduation
mark corresponding to the quantity in
millilitres (ml) prescribed by your doctor
(figure 5C).

d) Turn the bottle the right way up
(figure 6A). Remove the syringe from
the adaptor (figure 6B).

Do not stop taking the medicine
suddenly. This could lead to more
serious symptoms such as loss of
the sense of reality, feeling unreal
or detached from life, and unable to
feel emotion. Some patients have
also experienced numbness or
tingling of the arms or legs, tinnitus
(ringing sounds in the ears),
oversensitivity to light, sound and
touch, uncontrolled or overactive
movements, twitching, shaking,
feeling sick, being sick, stomach
upsets or stomach pain, loss of
appetite, agitation, abnormally fast
heartbeats, panic attacks, dizziness
or feeling that you are about to fall,
memory loss, hallucinations, feeling
stiff and unable to move easily,
feeling very warm, convulsions
(sudden uncontrolled shaking or
jerking of the body).

Patients taking anti-depressants
and patients with seizure disorders
may be more likely to experience
convulsions.
If you suffer from any of these
symptoms, ask your doctor for advice
immediately.


Reporting of side effects
If you get any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in this
leaflet. You can also report side effects
directly via the Yellow Card Scheme at
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help
provide more information on the safety
of this medicine.
5.










4.

Possible side effects

Like all medicines, Lorazepam can cause
side effects, although not everybody gets
them. These are usually not serious and
do not last long.
e) Empty the contents of the syringe
into the patient’s mouth by pushing the
piston to the bottom of the syringe
(figure 7). Close the bottle with the
plastic screw cap. Wash the syringe with
water (figure 8).

If you experience any of the following
more rare unwanted effects, you should
tell your doctor immediately (these
effects are more likely to occur in elderly
patients):




If you take more Lorazepam than
you should
If anyone has taken an overdose of
Lorazepam (that is more than the doctor
has prescribed), seek medical help
immediately, either by calling your
doctor, or going to the nearest casualty
department. Always take the labelled
medicine pack with you, even if no
medicine is left.
If you forget to take Lorazepam

If you forget to take your medicine
for anxiety, you should take it as
soon as you remember if it is less
than 3 hours since your usual time.
If more than 3 hours has passed
from when you usually take your
medicine, just take your next dose
when it is due.

Do not take a double dose to make
up for a forgotten dose.

If you forget to take your medicine
for sleeping problems, only take it if
you will be able to sleep for 7 to 8
hours afterwards.
If you stop taking Lorazepam

After you have finished your
prescribed treatment with
lorazepam, your doctor will decide if
you need further treatment.

The amount of Lorazepam and how
often you take your medicine should
always be reduced slowly before
stopping it. This allows your body to
get used to being without your
medicine, and reduces the risk of
unpleasant effects when you stop
taking the medicine. Your doctor
will tell you how to do this.

On stopping lorazepam, you may
experience symptoms such as
headaches, muscle pain, anxiety,
tension, depression, restlessness,
sweating, confusion or irritability.

Your original sleeplessness may also
return. If you suffer from any of
these symptoms, ask your doctor
for advice.

PIL/UK/MFG024/05/v6





Restlessness, agitation, irritability,
aggressiveness, violent anger,
sleeping difficulties, nightmares,
hallucinations, personality changes,
sexual arousal, abnormal behaviour
or false beliefs
Unexplained bleeding and/or
bruising; increased risk of infections
e.g. frequent sore throats, mouth
ulcers, weakness and pale skin as
these are symptoms of blood
dyscrasia
Severe allergic reactions e.g.
difficulty in breathing, swelling of
the lips, mouth, tongue, throat,
hands, feet and/or severe faintness
or dizziness
Jaundice e.g. yellowing of the skin,
eyes, nose, mouth, pale coloured
stools (faeces) and dark coloured
urine

However, you should tell your doctor if
any of the following symptoms are
severe or become troublesome:

Daytime drowsiness, dizziness,
reduced alertness, poor muscle
control, muscle weakness, fatigue,
hypersensitivity including
anaphylaxis (allergic reactions),
confusion, depression, numbed
emotions, difficulty controlling urges
and impulses to speak, act or show
emotions, a feeling of well-being for
no reason, appetite changes, sleep
problems, changes in sex drive,
decreased orgasm, thoughts of
harming or killing yourself,
becoming dependent on Lorazepam,
headache, slurred speech, memory
loss or forgetfulness, trembling or
shaking, impaired consciousness
(ultimately coma), problems with
vision including double vision or
blurred vision, worsening of sleep
apnoea e.g. loud snoring,
restlessness and choking/gasping
during the night, breathing
difficulties, stomach upsets, nausea,
constipation, changes in the amount
of saliva in the mouth, skin
problems such as rashes and
inflammation, erectile dysfunction
Other rare unwanted effects, which you
may not be aware of whilst taking
Lorazepam, include blood or liver
function changes, or low blood pressure,
or low body temperature.
If any of the side-effects get serious, or
if you notice any side-effects not listed
in this leaflet, please tell your doctor or
pharmacist.

How to store Lorazepam
1mg/ml Oral Solution

Keep out of the sight and reach of
children.
Do not use after the expiry date
which is printed on the carton and
bottle label after ‘Exp’. The expiry
date refers to the last day of that
month.
Store and transport refrigerated
(2°C – 8°C).
For 60ml pack size: Discard 30 days
after first opening.
For 150ml pack size: Discard 90 days
after first opening.
Keep the bottle in the outer carton in
order to protect from light.
Do not throw away any medicines
via wastewater or household waste.
Ask your pharmacist how to dispose
of medicines you no longer use.
These measures will help protect
the environment.

6.

Contents of the pack and
other information

What Lorazepam 1mg/ml Oral Solution
contains
The active substance is lorazepam.
Each ml of oral solution contains 1mg
lorazepam.
The other ingredients are ethanol (alcohol)
and medium chain triglycerides.
What Lorazepam 1mg/ml Oral Solution
looks like and contents of the pack
Lorazepam 1mg/ml Oral Solution is a clear,
colourless to pale yellow colour oral solution
supplied in an amber glass bottle, holding
60ml or 150ml of solution, with tamper
evident child resistant plastic cap. The pack
also contains a 1ml oral syringe and a
bottle/syringe adaptor.
Not all pack sizes may be marketed.
POM
Marketing Authorisation Holder and
Manufacturer:
Thame Laboratories,
Unit 4, Bradfield Road,
Ruislip, Middlesex,
HA4 0NU,
UK

If this leaflet is hard to see or read,
please call +44 (0) 208 515 3700 for
help.
This leaflet was last revised in 11/2016.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide